MDCE CRO

A Global Clinical Trial CRO Supporting the International Expansion of MedTech Companies Worldwide.

MDCE specializes in global clinical trials for MedTech companies, offering services such as clinical strategy, trial management, product registration, and global commercialization planning. With strong international resources, MDCE provides customized solutions to support companies' global expansion.

With a team of 100+ professionals, over 2,000 expert collaborations, and partnerships with 100+ renowned hospitals, MDCE has successfully supported 80+ projects worldwide, generating significant client profits across regions like the EU, North America, and Asia-Pacific.

To provide the personalised, quality services that meet or exceed our customers’ expectations at all times in a time cost-effective manner.
To provide services that meet customers’ needs at all times respecting 100% the applicable national or international regulations and other applicable requirements.
To ensure through continuous training and support a quality consciousness at all company levels.
To create and sustain a positive team-oriented environment for employee satisfaction.
To act at all times in an ethical/non-corrupting manner with customers, regulators, investigators and any other third parties we interact with.
To protect clients, staff and third parties of direct and indirect harm regarding Data Protection requirements.

2021

Pioneering Our Path in Global Clinical Research and Innovation

Global Expansion: MDCE established its presence in global clinical research, managing 15+ impactful projects across multiple regions, including Australia, United States, Europe, Asia, and Africa.
Diverse Therapeutic Areas: Projects spanned key fields such as Ophthalmology, Infectious Diseases, Cardiovascular, and Oncology, addressing pressing healthcare challenges.
Innovative Treatments: The company played a pivotal role in advancing COVID-19 diagnostics, lipid-lowering therapies, and oncolytic virus therapies for cancer.
Comprehensive Services: MDCE provided end-to-end support, offering services in clinical trials, regulatory affairs, and post-market follow-up.

2022

Expanding Global Reach and Advancing Healthcare Solutions

Global Growth: MDCE continued its global expansion, managing 10+ impactful projects across regions such as United States, Europe, Asia, and Africa.
Key Therapeutic Areas: Projects focused on Infectious Diseases, Cardiovascular, Hematology, and Medical Devices, addressing critical healthcare needs.
Innovative Clinical Development: Led the development and clinical trials of COVID-19 Antigen Home Self-Test, Nasal Spray Vaccine for COVID-19, Absorbable Hemostat for hemostasis, and Small RNA Drugs for chronic hepatitis B.
Healthcare Innovation: The company's efforts underscored its expertise in advancing healthcare solutions, driving innovation from development to market readiness.

2023

A Year of Significant Growth in Global Clinical Research and Development

Strong Global Expansion: MDCE managed 30+ projects across key regions including the United States, Europe, Asia, and Africa.
Therapeutic Areas Covered: MDCE managed projects across a broad range of therapeutic areas, including Infectious Diseases, Cardiovascular, CNS, Pulmonary Diseases, Endocrinology & Metabolic Diseases, Ophthalmology, Oncology, Gastroenterology, and Psychiatry, etc.
Key Products Driving Global Market Entry: MDCE successfully facilitated the global market entry for a range of groundbreaking medical devices and pharmaceuticals. Key highlights include: COVID-19 Vaccine、Intracranial Thrombectomy Stent、Ventricular Assist Device (VAD)、Oncolytic Virus Therapy、Gene Therapy for Parkinson's.
Regulatory Success & Global Reach: MDCE achieved significant regulatory milestones for devices and drugs across major markets, ensuring smooth approvals and global market readiness. Our expertise in navigating complex regulatory landscapes has been essential for facilitating global market access.

2024

Steady Development and Thriving Growth in Global Clinical Research

Expanding Therapeutic Focus and Global Reach：MDCE reached significant milestones in 2024 with 30+ innovative projects in Infectious Diseases, Cardiovascular, Neurology, Endocrinology, and Medical Devices across the United States, Europe, Asia, and Africa. Key projects included COVID-19 vaccines, vascular intervention devices, gene therapies, and diabetes monitoring systems.
Regulatory Growth and FDA Breakthrough Device Designation：2024 saw a large-scale expansion of MDCE's regulatory services, helping four Chinese companies obtain FDA Breakthrough Device Designation (BDD), underlining MDCE’s capability to navigate complex global regulatory landscapes.
Comprehensive Services from Development to Market：MDCE continued to excel in providing clinical trial management, regulatory support, and post-market follow-up, reinforcing its position as a key partner in advancing healthcare innovations worldwide.

We're hiring! Join our global team! Open roles: Clinical Research Associates (Europe, US, APAC), Regulatory Affairs Specialists, and Medical Experts. Let’s shape the future of healthcare together!

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MDCE CRO

Core Team

Xiaoyu DENG

Dmitry LUCHININ PhD

Victor Santiago JESUDOSS PhD

Sergey TABAKOV MD

Qian FU

Achirathalackal MATHAI PhD

Alvin Rogers

Quality Policy - ISO 9001 certified

Development History